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Radisson Blu

20 jun 2018 7:45 a.m. - 21 jun 2018 5:00 p.m.

Steinentorstrasse 25, 4001 Basel, Switzerland

DIA CMC Workshop

Session 7B: Biologics: Monographs and Standardisation

Session Chair(s)

Paul  Varley, PhD

Paul Varley, PhD

Vice President, Biopharmaceutical Development (Cambridge) Site Lead

MedImmune Ltd., United Kingdom

The question of how standardisation and Pharmacopoeial monographs can be used to ensure the quality of biological medicines remains a complex and challenging one. This session will aim to review this progress and discuss future challenges in this area.

Speaker(s)

Lionel  Randon

Industry View of Pharmacopoeial Monographs and Standardisation

Lionel Randon

Merck Serono, Switzerland

Head of GRA CMC Regulatory Intelligence & Ops

James  Pound

MHRA Perspectives on Pharmacopoeial Standards for Biological Medicines

James Pound

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Group Manager - British Pharmacopoeia & Laboratory Services

Mihaela  Buda, PhD

European Pharmacopoeia Texts for Biotherapeutic Products

Mihaela Buda, PhD

European Directorate for the Quality of Medicines & HealthCare (EDQM), France

Scientific Programme Manager, European Pharmacopoeia Department

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